http://www.fda.gov/cder/orange/appendix_a.txt 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 IMATINIB MESYLATE NOVARTIS < td WIDTH="75"> 21-335 SE5 003 28-Jun-02 20-May-03 Y 10.7 Provides for the use of Gleevec (imatinib mesylate) Tablets for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapyGEMIFLOXACIN MESYLATE GENESOFT PHARMS 21-158 SE1...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10,...
author: AUTHOR
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Factive (Gemifloxacin Mesylate) Tablets Company:- LG Life Sciences, Ltd
Fluoroquinolones for pneumonia - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Fluoroquinolones for pneumonia - [Medication] - Quest Diagnostics Patient Health Library Fluoroquinolones for pneumonia - [Medication] - Quest Diagnostics Patient Health Library Lungs and airways, Antibiotic, Antibiotics, Avelox, Factive, ...
UG_s01_s20 Activity Report 2004 Novartis Venture Fund Fostering Entrepreneurial Initiative in the Life Sciences Activity Report 2004 Letter from the Chairman and CEO Novartis In 2004, the Novartis Venture Fund invested in six new companies, three in Europe and three in the US, dedicating as well additional resources to companies already in the portfolio.
duplicates:http://www.novartis.com/downloads/VentureFundReport2004.pdf
BioPortfolio Limited Datamonitor believes that, while targeting UTIs will help to drive sales of fluoroquinolones, effective penetration of the RTI sector remains key to product success 6 Summary 8 Key metrics 9 Global quinolone sales by quarter, 2001-2002 9 Global quinolone sales forecasts by product, 2003-2011 10 Regional sales of fluoroquinolones, 2002-2008 11 CHAPTER 2 PRODUCT ANALYSES 18 Quinolones...
Approved Products_2004.xls 194 Jul- 02 Aranes p hyperglycosylated erythropoietin Chemotherapy- induced anemia Amgen 195 Jul- 02 X yrem Sodium oxybate oral solution Cataplexy associated with narcolepsy Orphan Medical 196 Au g- 02 Prestara Prasterone Lupus Genelabs 197 Se p- 02 Hepsera Adefovir dipivoxil Chronic Hepatitus B Gilead 198 Nov- 02 Mitoz ytrex Generic mitomycin Disseminated adenocarcinoma of the...
author: Reijer
Approved Products_2004.xls page 5
author: Reijer
CDER: Previous News Items 2003 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Previous News Items 2003 Previous News Items 2004 Previous News Items 2002 December 30, 2003 The prescribing information for Topamax (topiramate/topiramate capsules) has been revised to include a warning that Topamax causes hyperchloremic, non-anion gap metabolic acidosis (decreased serum...
FY 2003 NDA Approvals for New Molecular Entities FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -FY 2003 NDA Approvals for New Molecular Entities as of September 30, 2003 NDA # Trade Name (Generic Name) Dosage Form Applicant Date of- Approval Class Indication(s) 21-445 Zetia------ (ezetimibe)-- Tablets MSP Singapore -25-Oct-02 1S Zetia is indicated for (1) Primary hypercholesterolemia ...
DOCUMENT INFORMATION PAGE FACTIVE/ Supplement 001 00001 Labeling July 17, 2003 version PRESCRIBING INFORMATION FACTIVE ® (gemifloxacin mesylate) Tablets To reduce the development of drug- resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat infections that are proven or strongly suspected to be...
author: YUYO
DOCUMENT INFORMATION PAGE page 2
author: YUYO
DOCUMENT INFORMATION PAGE page 1
author: YUYO
DOCUMENT INFORMATION PAGE DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 158/ S- 001 GeneSoft Pharmaceuticals c/ o PAREXEL International Attention: Ms
author: YUYO
DOCUMENT INFORMATION PAGE page 1
author: YUYO
Factive Consumer Information Factive® Brand Name: Factive® Active Ingredient: - gemifloxacin mesylate Strength(s): 320mg Dosage Form(s): - Tablet Availability: ------- Prescription only Company Name: -- LG Life Sciences *Date Approved by FDA: April 4, 2003 *Approval by FDA does not mean that the drug is available to consumers at this time
http://www.fda.gov/cder/foi/label/2003/21158_factive_lbl.pdf SB- 265805/ Prescribing Information 000001 Confidential FACTIVE Gemifloxacin mesylate (SB- 265805) Item 2 Labeling LG Life Sciences Revised Version as of April 3, 2003 SB- 265805/ Prescribing Information 00002 Prescribing Information (Non- annotated) SB- 265805/ Prescribing Information 00003 April 3, 2003 version PRESCRIBING INFORMATION FACTIVE ® brand of ...
Factive Approval Letter.PDF Glifort: Please refer to your new drug application (NDA) dated December 15, 1999, received December 16, 1999, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Factive (gemifloxacin mesylate) Tablets, 320 mgFactive (gemifloxacin mesylate) Tablets for the treatment of community-...
author: YUYO
Factive Approval Letter.PDF page 2
author: YUYO
Factive Approval Letter.PDF page 1
author: YUYO
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt MELOXICAM JETMILLED AS MFG IN BIBERACH/RIB GERMANY 14432 30-Sep-99 ASAHI GLASS CO LTD PAROXETINE HYDROCHLORIDE AMORPHOUS AS MANUFACTURED IN ICHIHARA CITY CHIBA JAPAN 14436 05-Oct-99 FERMIC SA DE CV CLAVULANATE POTASSIUM AS MANUFACTURED IN MEXICO CITY MEXICO 14437 05-Oct-99 CIPLA LTD SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA 14439 23-Jun-99 SANYO FINE CO LTD ELS...
Database F F - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.Factive (1893) Factor VIII Gene Therapy (1690) Factor IX Gene Medicine ...
